NCT02519569

Brief Summary

A considerable proportion of bereaved individuals experience chronic and disabling grief (so-called complicated or prolonged grief). Complicated grief is associated with severe mental and physical health problems as well as impaired social and occupational functioning. Interventions based on cognitive-behavioral therapy and applied via the internet have shown to be efficacious for this condition, but have not yet been adapted and evaluated in Norway. The aim of the current study is to adapt an internet-based cognitive-behavioral intervention for complicated grief and evaluate its effectiveness as a pilot study.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

10 months

First QC Date

August 6, 2015

Last Update Submit

August 6, 2015

Conditions

Complicated Grief

Outcome Measures

Primary Outcomes (3)

  • Change from pretest to posttest in symptoms of complicated grief

    6 weeks

  • Change from pretest to follow-up (1) in symptoms of complicated grief

    18 weeks

  • Change from pretest to follow-up (2) in symptoms of complicated grief

    30 weeks

Secondary Outcomes (9)

  • Change from pretest to posttest in posttraumatic growth

    6 weeks

  • Change from pretest to follow-up (1) in posttraumatic growth

    18 weeks

  • Change from pretest to follow-up (2) in posttraumatic growth

    30 weeks

  • Change from pretest to posttest in quality of life

    6 weeks

  • Change from pretest to follow-up (1) in quality of life

    18 weeks

  • +4 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

Internet-based cognitive-behavioral therapy for complicated grief

Other: Internet-based cognitive-behavioral therapy

Interventions

Internet-based cognitive-behavioral therapyOTHER

The intervention consists of ten writing assignments

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complicated grief
  • Internet access
  • Fluent in Norwegian
  • No concomitant psychological treatment

You may not qualify if:

  • Severe depression
  • Psychotic symptoms
  • Dissociation
  • Suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Jens C. Thimm, PhD

CONTACT

90021044jens.thimm@uit.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 11, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

August 11, 2015

Record last verified: 2015-08